Cretex Medical, an innovative contract manufacturer for the medical device industry, was faced with a difficult challenge. Responsible for manufacturing a critical component for intravascular lithotripsy (IVL) catheter devices, they needed to find a way to optimize the daily work experience of their assembly team and scale up production at the same time.
“Think of this manual process as the extreme limits of what you can humanly do by manipulating tweezers under a microscope. The size of this assembly is not any bigger than an eyelash and the ergonomics of this repetitive process were taking a real physical and mental toll on our people,” describes Steve Lagergren, Manufacturing Engineering Supervisor, Cretex Medical.
The demand for this component was high and their customer was counting on them to scale up production. Jeremy Glynn, General Manager of Cretex Medical, Laser Division, adds, “There are patients at the end of the line who are depending on these intravascular therapies. We could not allow our assembly to create a disruption in supply.”
Cretex Medical turned to Arimation Robotics, a machine builder with a track record of solving difficult problems, for the answer.
Traditional robotic solutions were no match for the tiny component size and complicated 26-step manual process. The solution needed to automate and streamline the process of cutting wire, inserting in sleeves, crimping the parts together and inspecting the final component – all at micron level resolution.
“The majority of robotic products were too large and not accurate enough. We worked closely with the team at Cretex Medical to define requirements and perform feasibility testing to eliminate risk before building the automation,” explained Ari Pitkanen, Chief Executive Officer, Arimation Robotics.
Arimation brought in their value-added distributor, Mechatronic Solutions, to assist in recommending and sourcing the main parts. With their support, Arimation designed, built and tested a custom automation cell with three main elements:
- a Meca500, the six-axis robotic arm from Mecademic, selected for its small form factor and 5 micrometers repeatability for precision automation,
- an Asycube 50, the flexible feeding system with EYE+ from Asyril, built for tiny components and flexibility with advanced controls for integrators,
- and a custom wire feeding and cutting solution to accurately and consistently manipulate 0.1 mm thick wires.
“We build confidence with our customers when we can offer solutions to complex assembly challenges,” shared Steve. “It only seems natural that we would use the world’s smallest robot to handle some of the world’s smallest parts,” added Jeremy.
Cretex Medical identified three main areas of value resulting from this automation.
Healthy work environment
First and foremost was to improve the work environment for their operators. The automation allowed Cretex Medical an opportunity to shift the existing team to ergonomically healthy positions within the company.
“I worked on this component assembly process for 18 months. We knew that our customer was depending on our components so they could ultimately serve patients in need, so we stuck with it while this automation system was being built. Now, I am excited to have a new opportunity to learn how to run this automated cell, as well as learn other products. This particular micro assembly process is one where automation was clearly a better option,” shared Terri Harris, a Production Tech at Cretex Medical.
Increased throughput and higher yield
The growing demand for this component required the ability to scale up rapidly and with quality. “We needed a solution that could increase our output while ensuring we maintain a consistent, high quality assembly. Adding new operators was not the answer, but automation was,” described Jeremy.
Reduced Footprint of Assembly Line
While the manual process spanned over 12 feet, the automation is just 25% of that size with added benefit of being able to scale up within that same small footprint. “The size of the automated assembly line can fit in a carry-on suitcase. The small form factor matters to help us maximize our clean room space,” added Steve.
‘It is well known that miniaturization of medical devices will drive the next generation of technology. The smaller these medical devices are, the more applicable they are to a wider patient population,” shares Jeremy. Steve adds, “We see this level of automation – that being really small precision level – as transferable to almost all aspects of our company.” Finding that balance of automation and manual processes will continue to challenge medical device manufacturers as they seek ways to ensure workforce health and scale to meet demand for micron level components.